It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) had a bottle with two labels with one overlapping the other.No patient impact was reported.The following information was provided by the initial reporter: according to the customer's report, there was a bottle with 2 labels, one overlapping the other.
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It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) had a bottle with two labels with one overlapping the other.No patient impact was reported.The following information was provided by the initial reporter: according to the customer's report, there was a bottle with 2 labels, one overlapping the other.
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H6: investigation summary: a complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is confirmed based on photo sent by the customer.An assessment was performed by the engineering department to determine if the weiler labeler had mechanical issues and/or breakdowns during the packaging process of aforementioned batch.Investigation revealed that preventive maintenance activities to the weiler labeler machine was completed on time as scheduled.Upon evaluation of breakdowns / incidents reports, there were no malfunctions related to overlapping labels.In the production reports, there were multiple issues on the weiler labeler related to jams, machine out of synchronization and broken roll.These types of issues are resolved during the labeling process.The machine was inspected and was working as expected.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.No trend has been identified for the reported defect.No corrective actions required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
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